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Mallinckrodt
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Baxter
McKesson
Johnson and Johnson
Harvard Business School

Last Updated: December 9, 2019

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Hydralazine hydrochloride; isosorbide dinitrate - Generic Drug Details

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What are the generic drug sources for hydralazine hydrochloride; isosorbide dinitrate and what is the scope of freedom to operate?

Hydralazine hydrochloride; isosorbide dinitrate is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydralazine hydrochloride; isosorbide dinitrate has four patent family members in four countries.

There are twenty-one drug master file entries for hydralazine hydrochloride; isosorbide dinitrate. One supplier is listed for this compound.

Summary for hydralazine hydrochloride; isosorbide dinitrate
International Patents:4
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 21
Suppliers / Packagers: 1
Clinical Trials: 7
DailyMed Link:hydralazine hydrochloride; isosorbide dinitrate at DailyMed
Recent Clinical Trials for hydralazine hydrochloride; isosorbide dinitrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Aase og Ejnar Danielsen FoundationPhase 4
Henrik WiggersPhase 4
Danish Council for Independent ResearchPhase 4

See all hydralazine hydrochloride; isosorbide dinitrate clinical trials

Pharmacology for hydralazine hydrochloride; isosorbide dinitrate

US Patents and Regulatory Information for hydralazine hydrochloride; isosorbide dinitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Johnson and Johnson
Colorcon
Moodys
McKesson

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